First-Time Generic Drug Approvals: May 2008

  • Ropinirole Hydrochloride Tablets 0.25 mg (base), 0.5 mg (base), 1 mg (base), 2 mg (base), 3 mg (base) and 4 mg (base)
    Approved: May 5, 2008 Mylan Pharmaceuticals, Inc.; Roxane Laboratories, Inc.
    Generic for: Requip Tablets
  • Calcipotriene Topical Solution 0.005% (Scalp Solution)
    Approved: May 6, 2008 Nycomed US, Inc.
    Generic for: Dovonex Scalp Solution, 0.005%
  • Acarbose Tablets 25 mg, 50 mg, and 100 mg
    Approved: May 7, 2008 Roxane Laboratories, Inc.; Cobalt Laboratories
    Generic for: Precose Tablets
  • Drospirenone and Ethinyl Estradiol Tablets 3 mg/0.03 mg; (28-day regimen)
    Approved: May 9, 2008 Barr Laboratories, Inc.
    Generic for: Yasmin Tablets
  • Fluoxetine Capsules USP 10 mg and 20 mg
    Approved: May 20, 2008 Teva Pharmaceuticals USA
    Generic for: Sarafem Pulvules
  • Cetirizine Hydrochloride Syrup 1 mg/mL (Rx only)
    Approved: May 27, 2008 Teva Pharmaceuticals USA
    Generic for: Zyrtec Syrup (Rx only)
  • Omeprazole Delayed-Release Capsules USP, 40 mg
    Approved: May 30, 2008 Andrx Pharmaceuticals, LLC
    Generic for: Prilosec Delayed-Release Capsules 40 mg
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